Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers

Exclusion Criteria

• •Any current or previous known primary or secondary headache disorder(s) apart from tension type headache ≤ 1 day per month.
• •Headache \<48 hours before study start.
• •Daily use of any medication except contraceptives. Specifically use of nitrates or nitric oxide donors or phosphodiesterase inhibitors.
• •Intake of any pro necessitate medication later than 4 times plasma half-life for the specific drug before study start, except for contraceptives
• •Women of child-bearing potential not currently using safe contraceptives. Women of child-bearing potential does not include hysterectomized women and women who have been in menopause for at least 2 years. Safe contraceptives include either IUD, birth control pills, surgical sterilization of the woman, depositary gestagen, barrier prevention or sexual abstinence.
• •Pregnant or breastfeeding women
• •Positive pregnancy urin screening on screening day or study days.
• •A medical history or clinical signs of
• •* Hypertension (systolic blood pressure \>140mmHg and/or diastolic blood pressure \>90mmHg)
• •* Hypotension (systolic blood pressure \<100mmHg and/or diastolic blood pressure \<50mmHg)
• •Electrocardiogram (ECG) with any clinically significant abnormalities at screening determined by the investigator, including but not limited to, prolonged PQ or QTc interval, signs of arrythmias, ischemia or left/right ventricle dysfunction/hypertrophy.
• •Blood work at screening with signs of anemia.
• •Blood work at screening with signs of abnormal kidney and liver function.
• •A medical history or clinical signs of cardiovascular disease including cerebrovascular disease.
• •A medical history or clinical signs of pulmonary disease.
• •A medical history or clinical signs of liver, renal, gastrointestinal, endocrine, hematological or neurological disease.
• •A medical history or clinical signs of psychiatric illness or substance abuse
• •A medical history or clinical signs of drug or alcohol abuse
• •A medical history or clinical signs of disease of any origin that the investigative doctor finds relevant for participation in the study
• •A family history of severe cardiac disease.
• •Any history of hypersensitivity to riociguat.
• •Subjects who do not want information about crucial pathological findings during the study